European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomavirus vaccines - gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following hpv diseases:premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine hpv typesgenital warts (condyloma acuminata) caused by specific hpv types.see sections 4.4 and 5.1 for important information on the data that support these indications.the use of gardasil 9 should be in accordance with official recommendations.

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - human rotavirus a type g1p(8) strain rix4414 live antigen (unii: kz3l01d2pc) (human rotavirus a type g1p(8) strain rix4414 live antigen - unii:kz3l01d2pc) - human rotavirus a type g1p(8) strain rix4414 live antigen 1000000 [ccid_50] in 1 ml - rotarix is indicated for the prevention of rotavirus gastroenteritis caused by g1 and non-g1 types (g3, g4, and g9) when administered as a 2-dose series [see clinical studies (14.3)] . rotarix is approved for use in infants 6 weeks and up to 24 weeks of age. a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotarix should not receive further doses of rotarix. infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as meckel’s diverticulum) that would predispose the infant for intussusception should not receive rotarix. infants with a history of intussusception should not receive rotarix [see warnings and precautions (5.5)] . in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see adverse reactions (6.2)] . infants with severe combined immunodeficiency disease (scid) should not receive rotarix. postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having scid [see adverse reactions (6.2)] . safety and effectiveness of rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated. the effectiveness of rotarix in pre-term infants has not been established. safety data are available in pre-term infants (rotarix = 134, placebo = 120) with a reported gestational age ≤36 weeks. these pre-term infants were followed for saes up to 30 to 90 days after dose 2. saes were observed in 5.2% of recipients of rotarix as compared with 5.0% of placebo recipients. no deaths or cases of intussusception were reported in this population.

Kenya - English - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

United States - English - NLM (National Library of Medicine)

csl behring ag - human cytomegalovirus immune globulin (unii: 129l90a25n) (human cytomegalovirus immune globulin - unii:129l90a25n) - human cytomegalovirus immune globulin 50 mg in 1 ml - cytomegalovirus immune globulin intravenous (human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. in transplants of these organs other than kidney from cmv seropositive donors into seronegative recipients, prophylactic cmv-igiv should be considered in combination with ganciclovir. cytogam should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. persons with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin a, including cytogam.

United States - English - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gamunex-c is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gamunex-c is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gamunex-c is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gamunex-c is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gamunex-c is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gamunex-c is contraindicated in iga deficient patients with antibodies against iga and history of h

United States - English - NLM (National Library of Medicine)

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gammaked is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gammaked is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gammaked is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gammaked is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gammaked is contraindicated in iga deficient patients with antibodies against iga and history of hyperse

United States - English - NLM (National Library of Medicine)

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

United States - English - NLM (National Library of Medicine)

novartis vaccines and diagnostics limited - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated) (unii: h41xp0e6g8) (influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:w3d48fdo26) - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml

United States - English - NLM (National Library of Medicine)

csl behring llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - helixate® fs is a recombinant antihemophilic factor indicated for: helixate fs is not indicated for the treatment of von willebrand disease. helixate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). pregnancy category c animal reproduction studies have not been conducted with helixate fs. it is also not known whether helixate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. helixate fs should be given to a pregnant woman only if clearly needed. there is no information available on the effect of factor viii replacement therapy on labor and delivery. helixate fs should be used only if clinically needed. it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, caution sho

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - recombinant respiratory syncytial virus pre-fusion f protein (unii: m739eb7427) (recombinant respiratory syncytial virus pre-fusion f protein - unii:m739eb7427) - arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in individuals 60 years of age and older. do not administer arexvy to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of arexvy [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. arexvy is not approved for use in persons <60 years of age. in a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted rsv vaccine that contained the same rsvpref3 antigen as arexvy, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline). data in a randomized controlled clinical trial that enroll